Covid ICYMI

As we are all facing uncertainties in caring for our patients amid the COVID-19 pandemic, I wanted to share some thoughts I have had and some of my own experiences treating patients during this unsettling time. I practice at the University of Washington, Seattle, in an area that initially had the highest prevalence of COVID-19 cases in the United States.

I have never felt better about being a part of the medical profession because of the altruism, compassion, and deep caring I have seen displayed by my colleagues, our nurses, our staff, and our students. I am proud to have worked with all of them while trying to figure out how to practice in this environment.

These times are really difficult and challenging as we face new problems every day. Last week, we had to send our students home, and we switched to phone and telehealth visits to keep our patients and staff safer.

I have had some unanticipated electronic messages from patients during this time. Two of my patients with major medical problems and very dependent on their medications were stranded internationally and running out of medications. I had the family of an incarcerated patient contact me for a letter because that patient was moved to a part of a jail where all patients with upper respiratory infection symptoms were being housed. My patient has severe immunosuppression, and they were requesting an exception for him.

Another of my patients, who has sarcoidosis and is immunosuppressed, informed me that her daughter who lives with her was diagnosed with COVID-19. After 3 days, this patient told me she had become febrile and short of breath. I instructed her patient to go to a hospital, where she was also diagnosed with COVID-19 and was admitted. This patient was discharged within 24 hours, because the utilization review department did not feel she should be in the hospital.

The lack of beds is forcing physicians to frequently make tough decisions like the one made for this patient. This unfortunate reality raises the question of: “How do you manage a patient you are worried about from his or her home?”

In this particular case, I sent my patient an oxygen saturation monitor. We touched base frequently, and I felt okay as long as her saturations on room air were above 90%. So far, she has done okay.

More recently, I received a message from a patient recently diagnosed with Mycobacterium avium complex. I learned that this patient and her disabled husband’s caregiver refused to continue to provide care to them, because my patient had a cough, which began 2 months prior. In this case, a COVID-19 test was done for the explicit purpose of getting the caregiver to return to work.

So how do we face this?

Burnout had been high before this difficult time. But now physicians are being called to care for more and sicker patients without the necessary personal protective gear. Our physicians have demonstrated strength and commitment to patients in their response to this challenge, but they need help from others, including regulators.

I think a first step that needs to be taken is to decrease the volume of documentation physicians are required to make in this time where we are forced to triage to what is most important and drop what isn’t. How is spending so much time documenting instead of seeing the high volumes of patients who need to be seen a good thing? Documentation to the level that Medicare has required isn’t going to work. In fact, it has never been a good thing and is a big driver of burnout.

Our health care system was broken and badly injured before this crisis, and I think now might be a time when positive changes for the future occur. In fact, COVID-19 has resulted in some temporary changes in medicine that I would like to see outlast this outbreak. The telehealth option is now available, for example, and this kind of care is covered much more broadly by Medicare under the 1135 waiver – this has been needed for years. Being able to conduct regular clinic visits via telehealth without the marked restrictions that were previously in place is a big advance. It is currently in place for this emergency only, but this is the time to start pushing hard to make sure this option will be permanent.

I invite you to help me fight for long-term change. Write a letter to the editor of your local newspaper or blog, share your thoughts on social media, and tweet. (I suggest using #documentationordoctors or, although a bit long, #excessivedocumentationcostslives.) This is an unprecedented time in modern medicine. Traumatic times are when the greatest changes occur. Let’s hope for the better.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He frequently contributes Pearl of the Month and Myth of the Month columns to MDedge, and he serves on the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact Dr. Paauw at imnews@mdedge.com.

As we are all facing uncertainties in caring for our patients amid the COVID-19 pandemic, I wanted to share some thoughts I have had and some of my own experiences treating patients during this unsettling time. I practice at the University of Washington, Seattle, in an area that initially had the highest prevalence of COVID-19 cases in the United States.

I have never felt better about being a part of the medical profession because of the altruism, compassion, and deep caring I have seen displayed by my colleagues, our nurses, our staff, and our students. I am proud to have worked with all of them while trying to figure out how to practice in this environment.

These times are really difficult and challenging as we face new problems every day. Last week, we had to send our students home, and we switched to phone and telehealth visits to keep our patients and staff safer.

I have had some unanticipated electronic messages from patients during this time. Two of my patients with major medical problems and very dependent on their medications were stranded internationally and running out of medications. I had the family of an incarcerated patient contact me for a letter because that patient was moved to a part of a jail where all patients with upper respiratory infection symptoms were being housed. My patient has severe immunosuppression, and they were requesting an exception for him.

Another of my patients, who has sarcoidosis and is immunosuppressed, informed me that her daughter who lives with her was diagnosed with COVID-19. After 3 days, this patient told me she had become febrile and short of breath. I instructed her patient to go to a hospital, where she was also diagnosed with COVID-19 and was admitted. This patient was discharged within 24 hours, because the utilization review department did not feel she should be in the hospital.

The lack of beds is forcing physicians to frequently make tough decisions like the one made for this patient. This unfortunate reality raises the question of: “How do you manage a patient you are worried about from his or her home?”

In this particular case, I sent my patient an oxygen saturation monitor. We touched base frequently, and I felt okay as long as her saturations on room air were above 90%. So far, she has done okay.

More recently, I received a message from a patient recently diagnosed with Mycobacterium avium complex. I learned that this patient and her disabled husband’s caregiver refused to continue to provide care to them, because my patient had a cough, which began 2 months prior. In this case, a COVID-19 test was done for the explicit purpose of getting the caregiver to return to work.

So how do we face this?

Burnout had been high before this difficult time. But now physicians are being called to care for more and sicker patients without the necessary personal protective gear. Our physicians have demonstrated strength and commitment to patients in their response to this challenge, but they need help from others, including regulators.

I think a first step that needs to be taken is to decrease the volume of documentation physicians are required to make in this time where we are forced to triage to what is most important and drop what isn’t. How is spending so much time documenting instead of seeing the high volumes of patients who need to be seen a good thing? Documentation to the level that Medicare has required isn’t going to work. In fact, it has never been a good thing and is a big driver of burnout.

Our health care system was broken and badly injured before this crisis, and I think now might be a time when positive changes for the future occur. In fact, COVID-19 has resulted in some temporary changes in medicine that I would like to see outlast this outbreak. The telehealth option is now available, for example, and this kind of care is covered much more broadly by Medicare under the 1135 waiver – this has been needed for years. Being able to conduct regular clinic visits via telehealth without the marked restrictions that were previously in place is a big advance. It is currently in place for this emergency only, but this is the time to start pushing hard to make sure this option will be permanent.

I invite you to help me fight for long-term change. Write a letter to the editor of your local newspaper or blog, share your thoughts on social media, and tweet. (I suggest using #documentationordoctors or, although a bit long, #excessivedocumentationcostslives.) This is an unprecedented time in modern medicine. Traumatic times are when the greatest changes occur. Let’s hope for the better.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He frequently contributes Pearl of the Month and Myth of the Month columns to MDedge, and he serves on the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact Dr. Paauw at imnews@mdedge.com.

As we are all facing uncertainties in caring for our patients amid the COVID-19 pandemic, I wanted to share some thoughts I have had and some of my own experiences treating patients during this unsettling time. I practice at the University of Washington, Seattle, in an area that initially had the highest prevalence of COVID-19 cases in the United States.

I have never felt better about being a part of the medical profession because of the altruism, compassion, and deep caring I have seen displayed by my colleagues, our nurses, our staff, and our students. I am proud to have worked with all of them while trying to figure out how to practice in this environment.

These times are really difficult and challenging as we face new problems every day. Last week, we had to send our students home, and we switched to phone and telehealth visits to keep our patients and staff safer.

I have had some unanticipated electronic messages from patients during this time. Two of my patients with major medical problems and very dependent on their medications were stranded internationally and running out of medications. I had the family of an incarcerated patient contact me for a letter because that patient was moved to a part of a jail where all patients with upper respiratory infection symptoms were being housed. My patient has severe immunosuppression, and they were requesting an exception for him.

Another of my patients, who has sarcoidosis and is immunosuppressed, informed me that her daughter who lives with her was diagnosed with COVID-19. After 3 days, this patient told me she had become febrile and short of breath. I instructed her patient to go to a hospital, where she was also diagnosed with COVID-19 and was admitted. This patient was discharged within 24 hours, because the utilization review department did not feel she should be in the hospital.

The lack of beds is forcing physicians to frequently make tough decisions like the one made for this patient. This unfortunate reality raises the question of: “How do you manage a patient you are worried about from his or her home?”

In this particular case, I sent my patient an oxygen saturation monitor. We touched base frequently, and I felt okay as long as her saturations on room air were above 90%. So far, she has done okay.

More recently, I received a message from a patient recently diagnosed with Mycobacterium avium complex. I learned that this patient and her disabled husband’s caregiver refused to continue to provide care to them, because my patient had a cough, which began 2 months prior. In this case, a COVID-19 test was done for the explicit purpose of getting the caregiver to return to work.

So how do we face this?

Burnout had been high before this difficult time. But now physicians are being called to care for more and sicker patients without the necessary personal protective gear. Our physicians have demonstrated strength and commitment to patients in their response to this challenge, but they need help from others, including regulators.

I think a first step that needs to be taken is to decrease the volume of documentation physicians are required to make in this time where we are forced to triage to what is most important and drop what isn’t. How is spending so much time documenting instead of seeing the high volumes of patients who need to be seen a good thing? Documentation to the level that Medicare has required isn’t going to work. In fact, it has never been a good thing and is a big driver of burnout.

Our health care system was broken and badly injured before this crisis, and I think now might be a time when positive changes for the future occur. In fact, COVID-19 has resulted in some temporary changes in medicine that I would like to see outlast this outbreak. The telehealth option is now available, for example, and this kind of care is covered much more broadly by Medicare under the 1135 waiver – this has been needed for years. Being able to conduct regular clinic visits via telehealth without the marked restrictions that were previously in place is a big advance. It is currently in place for this emergency only, but this is the time to start pushing hard to make sure this option will be permanent.

I invite you to help me fight for long-term change. Write a letter to the editor of your local newspaper or blog, share your thoughts on social media, and tweet. (I suggest using #documentationordoctors or, although a bit long, #excessivedocumentationcostslives.) This is an unprecedented time in modern medicine. Traumatic times are when the greatest changes occur. Let’s hope for the better.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He frequently contributes Pearl of the Month and Myth of the Month columns to MDedge, and he serves on the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact Dr. Paauw at imnews@mdedge.com.

In the face of the COVID-19 pandemic, the American Academy of Neurology (AAN) is calling on the federal government to do more to expand telehealth services beyond Medicare.

On March 17, the Trump administration announced an expansion of telehealth benefits to help stop the spread of COVID-19 and allow more Medicare patients to receive virtual care without having to visit a healthcare center or physician office.

Under the expansion, Medicare will pay for office, hospital, and other visits furnished via telehealth across the country and including in the patient’s home, delivered by a range of providers, such as physicians, nurse practitioners, clinical psychologists, and licensed clinical social workers.

Prior to this waiver, Medicare would only pay for telehealth on a limited basis, such as when the patient receiving the service was in a designated rural area.

However, in a letter to Alex Azar, secretary of the U.S. Department of Health & Human Services (HHS), the AAN says the easing of restrictions on telehealth should be extended beyond Medicare fee-for-service to both Medicare Advantage and Medicaid patients.
 

Practice changing?

“It is very heartening that the government is stepping up to the plate” and lifting many telemedicine restrictions, Neil Busis, MD, member of the AAN Health Policy Subcommittee, said in an interview.

Dr. Busis, who leads the telemedicine program for the department of neurology at NYU Langone Health in New York, said the global pandemic has “heightened, focused, and sharpened” attention to the need for telehealth services, particularly for neurology.

“By definition, a lot of neurology patients have mobility problems, traveling is a burden, making it difficult to see a neurologist,” he said.

Dr. Busis hopes these waivers in telehealth, made on a temporary and emergency basis, will become permanent once the COVID-19 pandemic has passed.

“What we hope is that the usefulness of various virtual technologies tested in the crucible of this pandemic will stimulate people to think about it once the pandemic is over and not rescind these loosening of restrictions, and that this will be the beginning of a new era for telemedicine,” he said.

The COVID-19 pandemic may be a “catalyst to accelerate the incorporation of non-face-to-face care into our armamentarium,” he added.

“What we have discovered in recent years is non-face-to-face care with enabling communication technologies is as effective in many clinical situations as face-to-face care. Now is the time to really focus on making the virtual experience as good as possible and to make it as available to as many people as possible,” said Dr. Busis.
 

Reduce regulatory burdens

The AAN also calls on the federal government to urge states to take action to ensure access to telehealth services and allow telehealth companies to provide telehealth technology and education free of charge to providers who don’t currently use telehealth in their practices.

“The AAN notes that doing so may implicate provisions of the Anti-Kickback Statute. We believe during the current emergency that HHS should issue guidance making it clear to providers that accepting free access to telehealth platforms and education does not put them at risk of violating fraud and abuse laws,” the letter, signed by AAN President James Stevens, MD, stated.

The AAN also wants the government to reduce regulatory burdens during this public health emergency to allow physicians more time to focus on patient care. “This is especially true for providers that are self-quarantining or are in a practice that is experiencing staffing shortages due to self-quarantines,” he wrote.

Specifically, the AAN asked the Centers for Medicare & Medicaid Services to extend the March 31 deadline for physicians to submit their data for the Merit-based Incentive Payment System program for calendar year 2019 (and other compliance deadlines) by at least 30 days.

The AAN also calls on the CMS to delay implementation of the Appropriate Use Criteria program by 1 year, saying that many providers will not have the capacity to “meaningfully” participate in the current testing year for the program.

A version of this article originally appeared on Medscape.com.

In the face of the COVID-19 pandemic, the American Academy of Neurology (AAN) is calling on the federal government to do more to expand telehealth services beyond Medicare.

On March 17, the Trump administration announced an expansion of telehealth benefits to help stop the spread of COVID-19 and allow more Medicare patients to receive virtual care without having to visit a healthcare center or physician office.

Under the expansion, Medicare will pay for office, hospital, and other visits furnished via telehealth across the country and including in the patient’s home, delivered by a range of providers, such as physicians, nurse practitioners, clinical psychologists, and licensed clinical social workers.

Prior to this waiver, Medicare would only pay for telehealth on a limited basis, such as when the patient receiving the service was in a designated rural area.

However, in a letter to Alex Azar, secretary of the U.S. Department of Health & Human Services (HHS), the AAN says the easing of restrictions on telehealth should be extended beyond Medicare fee-for-service to both Medicare Advantage and Medicaid patients.
 

Practice changing?

“It is very heartening that the government is stepping up to the plate” and lifting many telemedicine restrictions, Neil Busis, MD, member of the AAN Health Policy Subcommittee, said in an interview.

Dr. Busis, who leads the telemedicine program for the department of neurology at NYU Langone Health in New York, said the global pandemic has “heightened, focused, and sharpened” attention to the need for telehealth services, particularly for neurology.

“By definition, a lot of neurology patients have mobility problems, traveling is a burden, making it difficult to see a neurologist,” he said.

Dr. Busis hopes these waivers in telehealth, made on a temporary and emergency basis, will become permanent once the COVID-19 pandemic has passed.

“What we hope is that the usefulness of various virtual technologies tested in the crucible of this pandemic will stimulate people to think about it once the pandemic is over and not rescind these loosening of restrictions, and that this will be the beginning of a new era for telemedicine,” he said.

The COVID-19 pandemic may be a “catalyst to accelerate the incorporation of non-face-to-face care into our armamentarium,” he added.

“What we have discovered in recent years is non-face-to-face care with enabling communication technologies is as effective in many clinical situations as face-to-face care. Now is the time to really focus on making the virtual experience as good as possible and to make it as available to as many people as possible,” said Dr. Busis.
 

Reduce regulatory burdens

The AAN also calls on the federal government to urge states to take action to ensure access to telehealth services and allow telehealth companies to provide telehealth technology and education free of charge to providers who don’t currently use telehealth in their practices.

“The AAN notes that doing so may implicate provisions of the Anti-Kickback Statute. We believe during the current emergency that HHS should issue guidance making it clear to providers that accepting free access to telehealth platforms and education does not put them at risk of violating fraud and abuse laws,” the letter, signed by AAN President James Stevens, MD, stated.

The AAN also wants the government to reduce regulatory burdens during this public health emergency to allow physicians more time to focus on patient care. “This is especially true for providers that are self-quarantining or are in a practice that is experiencing staffing shortages due to self-quarantines,” he wrote.

Specifically, the AAN asked the Centers for Medicare & Medicaid Services to extend the March 31 deadline for physicians to submit their data for the Merit-based Incentive Payment System program for calendar year 2019 (and other compliance deadlines) by at least 30 days.

The AAN also calls on the CMS to delay implementation of the Appropriate Use Criteria program by 1 year, saying that many providers will not have the capacity to “meaningfully” participate in the current testing year for the program.

A version of this article originally appeared on Medscape.com.

In the face of the COVID-19 pandemic, the American Academy of Neurology (AAN) is calling on the federal government to do more to expand telehealth services beyond Medicare.

On March 17, the Trump administration announced an expansion of telehealth benefits to help stop the spread of COVID-19 and allow more Medicare patients to receive virtual care without having to visit a healthcare center or physician office.

Under the expansion, Medicare will pay for office, hospital, and other visits furnished via telehealth across the country and including in the patient’s home, delivered by a range of providers, such as physicians, nurse practitioners, clinical psychologists, and licensed clinical social workers.

Prior to this waiver, Medicare would only pay for telehealth on a limited basis, such as when the patient receiving the service was in a designated rural area.

However, in a letter to Alex Azar, secretary of the U.S. Department of Health & Human Services (HHS), the AAN says the easing of restrictions on telehealth should be extended beyond Medicare fee-for-service to both Medicare Advantage and Medicaid patients.
 

Practice changing?

“It is very heartening that the government is stepping up to the plate” and lifting many telemedicine restrictions, Neil Busis, MD, member of the AAN Health Policy Subcommittee, said in an interview.

Dr. Busis, who leads the telemedicine program for the department of neurology at NYU Langone Health in New York, said the global pandemic has “heightened, focused, and sharpened” attention to the need for telehealth services, particularly for neurology.

“By definition, a lot of neurology patients have mobility problems, traveling is a burden, making it difficult to see a neurologist,” he said.

Dr. Busis hopes these waivers in telehealth, made on a temporary and emergency basis, will become permanent once the COVID-19 pandemic has passed.

“What we hope is that the usefulness of various virtual technologies tested in the crucible of this pandemic will stimulate people to think about it once the pandemic is over and not rescind these loosening of restrictions, and that this will be the beginning of a new era for telemedicine,” he said.

The COVID-19 pandemic may be a “catalyst to accelerate the incorporation of non-face-to-face care into our armamentarium,” he added.

“What we have discovered in recent years is non-face-to-face care with enabling communication technologies is as effective in many clinical situations as face-to-face care. Now is the time to really focus on making the virtual experience as good as possible and to make it as available to as many people as possible,” said Dr. Busis.
 

Reduce regulatory burdens

The AAN also calls on the federal government to urge states to take action to ensure access to telehealth services and allow telehealth companies to provide telehealth technology and education free of charge to providers who don’t currently use telehealth in their practices.

“The AAN notes that doing so may implicate provisions of the Anti-Kickback Statute. We believe during the current emergency that HHS should issue guidance making it clear to providers that accepting free access to telehealth platforms and education does not put them at risk of violating fraud and abuse laws,” the letter, signed by AAN President James Stevens, MD, stated.

The AAN also wants the government to reduce regulatory burdens during this public health emergency to allow physicians more time to focus on patient care. “This is especially true for providers that are self-quarantining or are in a practice that is experiencing staffing shortages due to self-quarantines,” he wrote.

Specifically, the AAN asked the Centers for Medicare & Medicaid Services to extend the March 31 deadline for physicians to submit their data for the Merit-based Incentive Payment System program for calendar year 2019 (and other compliance deadlines) by at least 30 days.

The AAN also calls on the CMS to delay implementation of the Appropriate Use Criteria program by 1 year, saying that many providers will not have the capacity to “meaningfully” participate in the current testing year for the program.

A version of this article originally appeared on Medscape.com.

Stephen M. Schwartz, MD, PhD, a pioneer in the field of vascular biology and a longtime professor of pathology at the University of Washington, Seattle, died March 17, 2020, after being hospitalized with COVID-19. He was 78.

“This has become all too real,” UW president Ana Mari Cauce said on Facebook, where she described Dr. Schwartz as “larger than life,” and superimposed a photo of him in front of Mount Rainier, according to a report in the Seattle Times.

Dr. Schwartz is “rightfully considered a giant among investigators of the biology of smooth muscle cells and the structure of blood vessels,” Paul Ramsey, MD, CEO of UW Medicine, said in a statement. He will be remembered for his “vigorous advocacy for research and for the field of vascular biology as well as for his many trainees who have gone on to great success as independent investigators in the field of vascular pathobiology,” Dr. Ramsey said.

Dr. Schwartz received a BA in biology from Harvard University in 1963 and an MD from Boston University in 1967. Dr. Schwartz started a residency in the UW department of pathology in 1967 and received his PhD from the institution in 1973. From 1974 to 1979, he was an assistant professor of pathology and became a full professor in 1984.

Dr. Schwartz was also an adjunct professor in the UW departments of bioengineering and medicine, “reflective of his many collaborative relationships with faculty in other departments in our medical school and in the world,” Dr. Ramsey said.

“Dr. Schwartz left a lasting imprint on the UW School of Medicine and the broader scientific community. He will be greatly missed,” he added.
 

‘A great loss’

Dr. Schwartz chaired numerous national and international meetings in the field of vascular biology. He was the founding chair of the Gordon Research Conference on Vascular Biology and a cofounder and second president of the North American Vascular Biology Organization (NAVBO). He created NAVBO’s flagship summer course, Vasculata.

“The NAVBO community has suffered a great loss,” Bernadette Englert, executive officer for the organization, said in a statement. He will be “sorely missed by generations of vascular biologists and pathologists.”

News of Dr. Schwartz’s passing lit up Twitter. Here are just a few comments:

UW lost to COVID-19 “beloved professor Stephen Schwartz, a pioneer in vascular biology and a larger-than-life scientist. Steve, you will be missed!” Rong Tian, MD, PhD, with the bioengineering department, wrote in a tweet.

“Stephen Schwartz was a giant in vascular biology and a mentor to countless faculty and trainees, including myself. He will be deeply missed,” said Kelly Stevens, PhD, also from the bioengineering department.

A version of this article originally appeared on Medscape.com.

Stephen M. Schwartz, MD, PhD, a pioneer in the field of vascular biology and a longtime professor of pathology at the University of Washington, Seattle, died March 17, 2020, after being hospitalized with COVID-19. He was 78.

“This has become all too real,” UW president Ana Mari Cauce said on Facebook, where she described Dr. Schwartz as “larger than life,” and superimposed a photo of him in front of Mount Rainier, according to a report in the Seattle Times.

Dr. Schwartz is “rightfully considered a giant among investigators of the biology of smooth muscle cells and the structure of blood vessels,” Paul Ramsey, MD, CEO of UW Medicine, said in a statement. He will be remembered for his “vigorous advocacy for research and for the field of vascular biology as well as for his many trainees who have gone on to great success as independent investigators in the field of vascular pathobiology,” Dr. Ramsey said.

Dr. Schwartz received a BA in biology from Harvard University in 1963 and an MD from Boston University in 1967. Dr. Schwartz started a residency in the UW department of pathology in 1967 and received his PhD from the institution in 1973. From 1974 to 1979, he was an assistant professor of pathology and became a full professor in 1984.

Dr. Schwartz was also an adjunct professor in the UW departments of bioengineering and medicine, “reflective of his many collaborative relationships with faculty in other departments in our medical school and in the world,” Dr. Ramsey said.

“Dr. Schwartz left a lasting imprint on the UW School of Medicine and the broader scientific community. He will be greatly missed,” he added.
 

‘A great loss’

Dr. Schwartz chaired numerous national and international meetings in the field of vascular biology. He was the founding chair of the Gordon Research Conference on Vascular Biology and a cofounder and second president of the North American Vascular Biology Organization (NAVBO). He created NAVBO’s flagship summer course, Vasculata.

“The NAVBO community has suffered a great loss,” Bernadette Englert, executive officer for the organization, said in a statement. He will be “sorely missed by generations of vascular biologists and pathologists.”

News of Dr. Schwartz’s passing lit up Twitter. Here are just a few comments:

UW lost to COVID-19 “beloved professor Stephen Schwartz, a pioneer in vascular biology and a larger-than-life scientist. Steve, you will be missed!” Rong Tian, MD, PhD, with the bioengineering department, wrote in a tweet.

“Stephen Schwartz was a giant in vascular biology and a mentor to countless faculty and trainees, including myself. He will be deeply missed,” said Kelly Stevens, PhD, also from the bioengineering department.

A version of this article originally appeared on Medscape.com.

Stephen M. Schwartz, MD, PhD, a pioneer in the field of vascular biology and a longtime professor of pathology at the University of Washington, Seattle, died March 17, 2020, after being hospitalized with COVID-19. He was 78.

“This has become all too real,” UW president Ana Mari Cauce said on Facebook, where she described Dr. Schwartz as “larger than life,” and superimposed a photo of him in front of Mount Rainier, according to a report in the Seattle Times.

Dr. Schwartz is “rightfully considered a giant among investigators of the biology of smooth muscle cells and the structure of blood vessels,” Paul Ramsey, MD, CEO of UW Medicine, said in a statement. He will be remembered for his “vigorous advocacy for research and for the field of vascular biology as well as for his many trainees who have gone on to great success as independent investigators in the field of vascular pathobiology,” Dr. Ramsey said.

Dr. Schwartz received a BA in biology from Harvard University in 1963 and an MD from Boston University in 1967. Dr. Schwartz started a residency in the UW department of pathology in 1967 and received his PhD from the institution in 1973. From 1974 to 1979, he was an assistant professor of pathology and became a full professor in 1984.

Dr. Schwartz was also an adjunct professor in the UW departments of bioengineering and medicine, “reflective of his many collaborative relationships with faculty in other departments in our medical school and in the world,” Dr. Ramsey said.

“Dr. Schwartz left a lasting imprint on the UW School of Medicine and the broader scientific community. He will be greatly missed,” he added.
 

‘A great loss’

Dr. Schwartz chaired numerous national and international meetings in the field of vascular biology. He was the founding chair of the Gordon Research Conference on Vascular Biology and a cofounder and second president of the North American Vascular Biology Organization (NAVBO). He created NAVBO’s flagship summer course, Vasculata.

“The NAVBO community has suffered a great loss,” Bernadette Englert, executive officer for the organization, said in a statement. He will be “sorely missed by generations of vascular biologists and pathologists.”

News of Dr. Schwartz’s passing lit up Twitter. Here are just a few comments:

UW lost to COVID-19 “beloved professor Stephen Schwartz, a pioneer in vascular biology and a larger-than-life scientist. Steve, you will be missed!” Rong Tian, MD, PhD, with the bioengineering department, wrote in a tweet.

“Stephen Schwartz was a giant in vascular biology and a mentor to countless faculty and trainees, including myself. He will be deeply missed,” said Kelly Stevens, PhD, also from the bioengineering department.

A version of this article originally appeared on Medscape.com.

Annie Luetkemeyer, MD, professor of infectious diseases at UCSF, is an expert on the treatment of viral infections. Robert Wachter, MD, MHM, chair of the UCSF Department of Medicine, interviewed her about the evidence behind potential treatments for COVID-19 (including chloroquine/hydroxychloroquine, remdesivir, and others), as well as how to assess new and existing drugs in a pandemic.

Annie Luetkemeyer, MD, professor of infectious diseases at UCSF, is an expert on the treatment of viral infections. Robert Wachter, MD, MHM, chair of the UCSF Department of Medicine, interviewed her about the evidence behind potential treatments for COVID-19 (including chloroquine/hydroxychloroquine, remdesivir, and others), as well as how to assess new and existing drugs in a pandemic.

Annie Luetkemeyer, MD, professor of infectious diseases at UCSF, is an expert on the treatment of viral infections. Robert Wachter, MD, MHM, chair of the UCSF Department of Medicine, interviewed her about the evidence behind potential treatments for COVID-19 (including chloroquine/hydroxychloroquine, remdesivir, and others), as well as how to assess new and existing drugs in a pandemic.

Recommendations to help clinicians triage surgical procedures during the COVID-19 pandemic, developed quickly by a team of urology experts from around the world and shared last week, are already out of date.

“I would change some things we said a week ago,” said David Canes, MD, from Lahey Hospital and Medical Center in Burlington, Massachusetts, and Derry, New Hampshire, who was one of those experts.

“We now know it’s not possible to create a cookbook in the face of a rapidly evolving pandemic,” he told Medscape Medical News.

“It’s heartening that we could do it so fast, but now it’s a snapshot in time, a starting point. People have to have conversations locally, in their community, taking into account where they are in relation to a surge of COVID patients, to make good decisions,” Canes said.

Long-thought-out guidance can no longer come from societies. “As the pace of information changes so rapidly,” Canes said he has changed the way he disseminates information and searches for guidance. “I’m even looking to nontraditional channels, like Twitter.”

As the COVID-19 pandemic evolves, informal discussions on social media are helping specialists make decisions. “Threads about various cancers and how people are handling them are helpful,” he said.

He described, for example, a thoughtful discussion on the use of androgen-deprivation therapy, a hormone therapy that can block the effects of androgens and can slow the growth of prostate cancer. “This is not a standard-of-care treatment,” he said, but now it’s being discussed very seriously to treat patients whose care might get delayed.

A multiple-choice survey was posted on Twitter by Ashish Kamat, MD, MBBS, from the MD Anderson Cancer Center in Houston, asking respondents what they would do for a patient with stage T2 high-grade muscle invasive bladder cancer and normal glomerular filtration during the pandemic.

In less than 20 hours, his post received 290 votes in response.

And when Badar Mian, MD, from the Albany Medical Center in New York, asked 23 urologists whether they would recommend radiotherapy (20 fractions) without any chemotherapy, he quickly got two responses: one yes and one no, with explanations.

People are responding to posts quickly. “With the COVID pandemic, we can’t wait for consensus guidelines from the American Urology Association or European Association of Urology,” Canes said.
 

One Week Changed Everything

When Canes and his coauthors said last week that prostatectomies should be delayed, they didn’t know the extent to which surgery was going to be halted. “When we wrote this statement, most facilities were still allowing elective surgeries or were just on the cusp of shutting down.”

Today, if you’re in an area where elective surgeries are still allowed or it is early in the crisis, “you might still take a patient with a Gleason 9 and a PSA of 25 and judiciously get the surgery done.”

As of March 23, however, surgery in New York City is entirely off the table. “No cancer surgery is happening anymore,” Canes reported.

The recommendations suggested using “shared decision-making” to guide radiation therapy choices. “But now, bringing a patient in for daily radiation treatment may not even be feasible, with the effort it takes to clean, the consumption of PPEs, etc,” he added.

When the dust settles, there will be a lot of assessment of current decision-making. “We’ll see if there are blips in mortality according to decisions being made,” Canes said.

The bottom line is that “we’re running on a 24-hour news cycle,” he pointed out. “It’s humbling to see how quickly decision-making changes and how nimble we have to be in making these very difficult decisions that we’ve never had to make before.”

For his own patients, Canes said he is doing consultations by phone or video at this point. “My patients have been very gracious; everyone has a general feeling we’re all in this together.”

And so far, “I haven’t had a situation where I thought the patient wasn’t going to survive,” he added.

This article first appeared on Medscape.com.

Recommendations to help clinicians triage surgical procedures during the COVID-19 pandemic, developed quickly by a team of urology experts from around the world and shared last week, are already out of date.

“I would change some things we said a week ago,” said David Canes, MD, from Lahey Hospital and Medical Center in Burlington, Massachusetts, and Derry, New Hampshire, who was one of those experts.

“We now know it’s not possible to create a cookbook in the face of a rapidly evolving pandemic,” he told Medscape Medical News.

“It’s heartening that we could do it so fast, but now it’s a snapshot in time, a starting point. People have to have conversations locally, in their community, taking into account where they are in relation to a surge of COVID patients, to make good decisions,” Canes said.

Long-thought-out guidance can no longer come from societies. “As the pace of information changes so rapidly,” Canes said he has changed the way he disseminates information and searches for guidance. “I’m even looking to nontraditional channels, like Twitter.”

As the COVID-19 pandemic evolves, informal discussions on social media are helping specialists make decisions. “Threads about various cancers and how people are handling them are helpful,” he said.

He described, for example, a thoughtful discussion on the use of androgen-deprivation therapy, a hormone therapy that can block the effects of androgens and can slow the growth of prostate cancer. “This is not a standard-of-care treatment,” he said, but now it’s being discussed very seriously to treat patients whose care might get delayed.

A multiple-choice survey was posted on Twitter by Ashish Kamat, MD, MBBS, from the MD Anderson Cancer Center in Houston, asking respondents what they would do for a patient with stage T2 high-grade muscle invasive bladder cancer and normal glomerular filtration during the pandemic.

In less than 20 hours, his post received 290 votes in response.

And when Badar Mian, MD, from the Albany Medical Center in New York, asked 23 urologists whether they would recommend radiotherapy (20 fractions) without any chemotherapy, he quickly got two responses: one yes and one no, with explanations.

People are responding to posts quickly. “With the COVID pandemic, we can’t wait for consensus guidelines from the American Urology Association or European Association of Urology,” Canes said.
 

One Week Changed Everything

When Canes and his coauthors said last week that prostatectomies should be delayed, they didn’t know the extent to which surgery was going to be halted. “When we wrote this statement, most facilities were still allowing elective surgeries or were just on the cusp of shutting down.”

Today, if you’re in an area where elective surgeries are still allowed or it is early in the crisis, “you might still take a patient with a Gleason 9 and a PSA of 25 and judiciously get the surgery done.”

As of March 23, however, surgery in New York City is entirely off the table. “No cancer surgery is happening anymore,” Canes reported.

The recommendations suggested using “shared decision-making” to guide radiation therapy choices. “But now, bringing a patient in for daily radiation treatment may not even be feasible, with the effort it takes to clean, the consumption of PPEs, etc,” he added.

When the dust settles, there will be a lot of assessment of current decision-making. “We’ll see if there are blips in mortality according to decisions being made,” Canes said.

The bottom line is that “we’re running on a 24-hour news cycle,” he pointed out. “It’s humbling to see how quickly decision-making changes and how nimble we have to be in making these very difficult decisions that we’ve never had to make before.”

For his own patients, Canes said he is doing consultations by phone or video at this point. “My patients have been very gracious; everyone has a general feeling we’re all in this together.”

And so far, “I haven’t had a situation where I thought the patient wasn’t going to survive,” he added.

This article first appeared on Medscape.com.

Recommendations to help clinicians triage surgical procedures during the COVID-19 pandemic, developed quickly by a team of urology experts from around the world and shared last week, are already out of date.

“I would change some things we said a week ago,” said David Canes, MD, from Lahey Hospital and Medical Center in Burlington, Massachusetts, and Derry, New Hampshire, who was one of those experts.

“We now know it’s not possible to create a cookbook in the face of a rapidly evolving pandemic,” he told Medscape Medical News.

“It’s heartening that we could do it so fast, but now it’s a snapshot in time, a starting point. People have to have conversations locally, in their community, taking into account where they are in relation to a surge of COVID patients, to make good decisions,” Canes said.

Long-thought-out guidance can no longer come from societies. “As the pace of information changes so rapidly,” Canes said he has changed the way he disseminates information and searches for guidance. “I’m even looking to nontraditional channels, like Twitter.”

As the COVID-19 pandemic evolves, informal discussions on social media are helping specialists make decisions. “Threads about various cancers and how people are handling them are helpful,” he said.

He described, for example, a thoughtful discussion on the use of androgen-deprivation therapy, a hormone therapy that can block the effects of androgens and can slow the growth of prostate cancer. “This is not a standard-of-care treatment,” he said, but now it’s being discussed very seriously to treat patients whose care might get delayed.

A multiple-choice survey was posted on Twitter by Ashish Kamat, MD, MBBS, from the MD Anderson Cancer Center in Houston, asking respondents what they would do for a patient with stage T2 high-grade muscle invasive bladder cancer and normal glomerular filtration during the pandemic.

In less than 20 hours, his post received 290 votes in response.

And when Badar Mian, MD, from the Albany Medical Center in New York, asked 23 urologists whether they would recommend radiotherapy (20 fractions) without any chemotherapy, he quickly got two responses: one yes and one no, with explanations.

People are responding to posts quickly. “With the COVID pandemic, we can’t wait for consensus guidelines from the American Urology Association or European Association of Urology,” Canes said.
 

One Week Changed Everything

When Canes and his coauthors said last week that prostatectomies should be delayed, they didn’t know the extent to which surgery was going to be halted. “When we wrote this statement, most facilities were still allowing elective surgeries or were just on the cusp of shutting down.”

Today, if you’re in an area where elective surgeries are still allowed or it is early in the crisis, “you might still take a patient with a Gleason 9 and a PSA of 25 and judiciously get the surgery done.”

As of March 23, however, surgery in New York City is entirely off the table. “No cancer surgery is happening anymore,” Canes reported.

The recommendations suggested using “shared decision-making” to guide radiation therapy choices. “But now, bringing a patient in for daily radiation treatment may not even be feasible, with the effort it takes to clean, the consumption of PPEs, etc,” he added.

When the dust settles, there will be a lot of assessment of current decision-making. “We’ll see if there are blips in mortality according to decisions being made,” Canes said.

The bottom line is that “we’re running on a 24-hour news cycle,” he pointed out. “It’s humbling to see how quickly decision-making changes and how nimble we have to be in making these very difficult decisions that we’ve never had to make before.”

For his own patients, Canes said he is doing consultations by phone or video at this point. “My patients have been very gracious; everyone has a general feeling we’re all in this together.”

And so far, “I haven’t had a situation where I thought the patient wasn’t going to survive,” he added.

This article first appeared on Medscape.com.

The Food and Drug Administration identified a number of medical devices that can be used to help treat patients suffering from COVID-19 if ventilators are not available. “Whenever possible, health care facilities should use FDA-cleared conventional/standard full-featured ventilators when necessary to support patients with respiratory failure, or a device subject to an Emergency Use Authorization (EUA), if any,” FDA stated in a guidance document issued March 22.

“However, to help ensure the availability of the greatest possible number of devices for this purpose, ... FDA does not intend to object to limited modifications to indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices used to support patients with respiratory failure or respiratory insufficiency, without prior submission of a premarket notification” for the duration of the declared national emergency related to the COVID-19 pandemic.

FDA Commissioner Stephen Hahn, MD, said in a statement that the agency is doing everything it can to support patients, health care professionals, and others during this pandemic.

“One of the most impactful steps we can take is to help with access and availability to life-saving medical treatments,” he said. “Our policy issued today demonstrates our ability to react and adapt quickly during this pandemic and help very ill patients access the lifesaving ventilator support they need. To do that, we are providing maximum regulatory flexibility to facilitate an increase in ventilator inventory, while still providing crucial FDA oversight. We believe this action will immediately increase ventilator availability.”

The document identified examples of where modifications would not create undue risk, including the use of powered emergency ventilators and anesthesia gas machines for patients needing mechanical ventilation; the use of ventilators outside of their cleared environment; the use of devices used to treat patients with sleep apnea, such as CPAPs and BiPAPs, to treat respiratory insufficiency when appropriate design mitigations are in place to minimize aerosolization; and the use of oxygen concentrators for primary supply when medically necessary and clinically appropriate.

The agency also is allowing for changes to the hardware, software, and materials to FDA-cleared ventilators and anesthesia gas machines, such as modifications to motors, batteries, or other electrical components; material changes to components in the gas pathways or with other patient tissue contact; the introduction of filtration to minimize aerosolization; and other hardware and software modifications.

FDA is also allowing for products to be used past their indicated shelf life.

gtwatchtman@mdege.com

The Food and Drug Administration identified a number of medical devices that can be used to help treat patients suffering from COVID-19 if ventilators are not available. “Whenever possible, health care facilities should use FDA-cleared conventional/standard full-featured ventilators when necessary to support patients with respiratory failure, or a device subject to an Emergency Use Authorization (EUA), if any,” FDA stated in a guidance document issued March 22.

“However, to help ensure the availability of the greatest possible number of devices for this purpose, ... FDA does not intend to object to limited modifications to indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices used to support patients with respiratory failure or respiratory insufficiency, without prior submission of a premarket notification” for the duration of the declared national emergency related to the COVID-19 pandemic.

FDA Commissioner Stephen Hahn, MD, said in a statement that the agency is doing everything it can to support patients, health care professionals, and others during this pandemic.

“One of the most impactful steps we can take is to help with access and availability to life-saving medical treatments,” he said. “Our policy issued today demonstrates our ability to react and adapt quickly during this pandemic and help very ill patients access the lifesaving ventilator support they need. To do that, we are providing maximum regulatory flexibility to facilitate an increase in ventilator inventory, while still providing crucial FDA oversight. We believe this action will immediately increase ventilator availability.”

The document identified examples of where modifications would not create undue risk, including the use of powered emergency ventilators and anesthesia gas machines for patients needing mechanical ventilation; the use of ventilators outside of their cleared environment; the use of devices used to treat patients with sleep apnea, such as CPAPs and BiPAPs, to treat respiratory insufficiency when appropriate design mitigations are in place to minimize aerosolization; and the use of oxygen concentrators for primary supply when medically necessary and clinically appropriate.

The agency also is allowing for changes to the hardware, software, and materials to FDA-cleared ventilators and anesthesia gas machines, such as modifications to motors, batteries, or other electrical components; material changes to components in the gas pathways or with other patient tissue contact; the introduction of filtration to minimize aerosolization; and other hardware and software modifications.

FDA is also allowing for products to be used past their indicated shelf life.

gtwatchtman@mdege.com

The Food and Drug Administration identified a number of medical devices that can be used to help treat patients suffering from COVID-19 if ventilators are not available. “Whenever possible, health care facilities should use FDA-cleared conventional/standard full-featured ventilators when necessary to support patients with respiratory failure, or a device subject to an Emergency Use Authorization (EUA), if any,” FDA stated in a guidance document issued March 22.

“However, to help ensure the availability of the greatest possible number of devices for this purpose, ... FDA does not intend to object to limited modifications to indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices used to support patients with respiratory failure or respiratory insufficiency, without prior submission of a premarket notification” for the duration of the declared national emergency related to the COVID-19 pandemic.

FDA Commissioner Stephen Hahn, MD, said in a statement that the agency is doing everything it can to support patients, health care professionals, and others during this pandemic.

“One of the most impactful steps we can take is to help with access and availability to life-saving medical treatments,” he said. “Our policy issued today demonstrates our ability to react and adapt quickly during this pandemic and help very ill patients access the lifesaving ventilator support they need. To do that, we are providing maximum regulatory flexibility to facilitate an increase in ventilator inventory, while still providing crucial FDA oversight. We believe this action will immediately increase ventilator availability.”

The document identified examples of where modifications would not create undue risk, including the use of powered emergency ventilators and anesthesia gas machines for patients needing mechanical ventilation; the use of ventilators outside of their cleared environment; the use of devices used to treat patients with sleep apnea, such as CPAPs and BiPAPs, to treat respiratory insufficiency when appropriate design mitigations are in place to minimize aerosolization; and the use of oxygen concentrators for primary supply when medically necessary and clinically appropriate.

The agency also is allowing for changes to the hardware, software, and materials to FDA-cleared ventilators and anesthesia gas machines, such as modifications to motors, batteries, or other electrical components; material changes to components in the gas pathways or with other patient tissue contact; the introduction of filtration to minimize aerosolization; and other hardware and software modifications.

FDA is also allowing for products to be used past their indicated shelf life.

gtwatchtman@mdege.com

Several days ago, Rodney Bordeaux, president of the Rosebud Sioux Tribe in South Dakota, sent a strongly worded SOS to the directors of the World Health Organization and the Pan American Health Organization about COVID-19, saying, “We have approximately 30,000 tribal members living in south central South Dakota with access to fewer than 200 beds within our reservation.”

Not only were beds woefully inadequate to the needs of potential COVID-19 victims, but tests to find out who might need the beds also were lacking. “We believe that some kits have been sent to the states,” Bordeaux wrote, “but it is the states that have been determining who gets a test and who does not.”

In Michigan, Aaron Payment, chair of the Sault Ste. Marie Tribe of Chippewa Indians, told the Native America Calling radio show, “We’re the largest tribe east of the Mississippi, and we have two test kits.”

The “chronically underfunded” Indian Health Service (IHS) was underprepared for handling virus response, Melissa Riley, PhD, executive director of Indigenous Women Rising, charged in a March 24 opinion piece in Rewire News. “If IHS can barely keep up with broken bones and preventive care,” she wrote, “what makes our people across the country think IHS can handle the outbreak of COVID-19?”  

The Centers for Disease Control and Prevention (CDC) does not break down data on cases according to race or ethnicity, but according to the IHS website, 42 people in the agency’s jurisdiction had tested positive for COVID-19 as of Mar. 24. Of those, 29 were in Navajo Country. By the evening of that day, according to Native News Online, the number of Navajos testing positive had risen to 49. Given the often-invisible spread of the virus, many more are likely to be infected.

The IHS website directs visitors to visit CDC pages for more information. However, these pages do not provide information “in a culturally literate and responsive manner,” Riley says, that explain ways to stay indoors, nor do they offer contacts for indigenous people—despite the fact, she adds, that on the West Coast they were among the first to contract the virus and to reach out with questions.

For its part, the IHS has said it “continues to work closely with our tribal partners to coordinate a comprehensive public health response to COVID-19,” holding weekly conference calls with tribal and urban Indian health organization leaders to “provide updates, answer questions, and hear concerns.” It also is in constant contact with the White House and the CDC, IHS says. IHS facilities “generally” have access to testing for individuals who may have COVID-19, the website says: However, “there are nationwide shortages of materials that may temporarily affect the availability of COVID-19 testing at a particular location.” Tribes, the website recommends, should first follow their usual process for ordering supplies. If they can’t access supplies, they should contact their IHS Area Office, which can access supplies through the IH National Supply Service Center.

Bordeaux, Payment, and Riley are not alone in their criticisms and concerns. Native Americans and Alaska Natives were hit disproportionately during the 2009 H1N1 influenza pandemic: The death rate was 4 times higher than in all other racial and ethnic groups combined. The NIH says AI/ANs are particularly vulnerable to epidemic infections, due to poverty, underlying chronic illnesses (including asthma), and delayed access to care.

Tribes began taking steps early on to protect their members, even before the federal and state governments began requiring such measures. Lummi Nation leaders, in the Pacific Northwest, for instance, began preparing when the virus first appeared in Wuhan in late 2019, according to an article in The Guardian, and declared a state of emergency on March 3—10 days before President Trump did.

The tribe has been “beefing up” emergency plans, reorganizing services, and gathering medical supplies. It also approved $1 million for emergency response, including repurposing a community fitness center into a field hospital. “We quickly recognized the need to make sacrifices for the greater good, in order to protect our people and the wider community,” Dr. Dakotah Lane, medical director of the tribal health service, said in the Guardian interview.

On March 17, the Navajo Nation shut down its 4 casinos after an Arizona tribe member was diagnosed with the virus. President Jonathan Nez says the tribe stands to lose $3 million to $5 million in revenue. But “[t]he health and well-being of our Navajo people is of utmost importance and not just profit,” Nez said in a Navajo Times interview.

In the meantime, bending to pressure from Rep. Deb Haaland (D-NM) and “a handful” of other lawmakers, according to an article in The Guardian, Congress designated $40 million for tribal health and Urban Indian Health organizations as part of the emergency federal relief legislation.

While the states received the emergency funds immediately, the CDC disburses the money to tribes, who have yet to receive any. Haaland, the first Native American woman elected to Congress, says the tribes needed the money “yesterday.”

Several days ago, Rodney Bordeaux, president of the Rosebud Sioux Tribe in South Dakota, sent a strongly worded SOS to the directors of the World Health Organization and the Pan American Health Organization about COVID-19, saying, “We have approximately 30,000 tribal members living in south central South Dakota with access to fewer than 200 beds within our reservation.”

Not only were beds woefully inadequate to the needs of potential COVID-19 victims, but tests to find out who might need the beds also were lacking. “We believe that some kits have been sent to the states,” Bordeaux wrote, “but it is the states that have been determining who gets a test and who does not.”

In Michigan, Aaron Payment, chair of the Sault Ste. Marie Tribe of Chippewa Indians, told the Native America Calling radio show, “We’re the largest tribe east of the Mississippi, and we have two test kits.”

The “chronically underfunded” Indian Health Service (IHS) was underprepared for handling virus response, Melissa Riley, PhD, executive director of Indigenous Women Rising, charged in a March 24 opinion piece in Rewire News. “If IHS can barely keep up with broken bones and preventive care,” she wrote, “what makes our people across the country think IHS can handle the outbreak of COVID-19?”  

The Centers for Disease Control and Prevention (CDC) does not break down data on cases according to race or ethnicity, but according to the IHS website, 42 people in the agency’s jurisdiction had tested positive for COVID-19 as of Mar. 24. Of those, 29 were in Navajo Country. By the evening of that day, according to Native News Online, the number of Navajos testing positive had risen to 49. Given the often-invisible spread of the virus, many more are likely to be infected.

The IHS website directs visitors to visit CDC pages for more information. However, these pages do not provide information “in a culturally literate and responsive manner,” Riley says, that explain ways to stay indoors, nor do they offer contacts for indigenous people—despite the fact, she adds, that on the West Coast they were among the first to contract the virus and to reach out with questions.

For its part, the IHS has said it “continues to work closely with our tribal partners to coordinate a comprehensive public health response to COVID-19,” holding weekly conference calls with tribal and urban Indian health organization leaders to “provide updates, answer questions, and hear concerns.” It also is in constant contact with the White House and the CDC, IHS says. IHS facilities “generally” have access to testing for individuals who may have COVID-19, the website says: However, “there are nationwide shortages of materials that may temporarily affect the availability of COVID-19 testing at a particular location.” Tribes, the website recommends, should first follow their usual process for ordering supplies. If they can’t access supplies, they should contact their IHS Area Office, which can access supplies through the IH National Supply Service Center.

Bordeaux, Payment, and Riley are not alone in their criticisms and concerns. Native Americans and Alaska Natives were hit disproportionately during the 2009 H1N1 influenza pandemic: The death rate was 4 times higher than in all other racial and ethnic groups combined. The NIH says AI/ANs are particularly vulnerable to epidemic infections, due to poverty, underlying chronic illnesses (including asthma), and delayed access to care.

Tribes began taking steps early on to protect their members, even before the federal and state governments began requiring such measures. Lummi Nation leaders, in the Pacific Northwest, for instance, began preparing when the virus first appeared in Wuhan in late 2019, according to an article in The Guardian, and declared a state of emergency on March 3—10 days before President Trump did.

The tribe has been “beefing up” emergency plans, reorganizing services, and gathering medical supplies. It also approved $1 million for emergency response, including repurposing a community fitness center into a field hospital. “We quickly recognized the need to make sacrifices for the greater good, in order to protect our people and the wider community,” Dr. Dakotah Lane, medical director of the tribal health service, said in the Guardian interview.

On March 17, the Navajo Nation shut down its 4 casinos after an Arizona tribe member was diagnosed with the virus. President Jonathan Nez says the tribe stands to lose $3 million to $5 million in revenue. But “[t]he health and well-being of our Navajo people is of utmost importance and not just profit,” Nez said in a Navajo Times interview.

In the meantime, bending to pressure from Rep. Deb Haaland (D-NM) and “a handful” of other lawmakers, according to an article in The Guardian, Congress designated $40 million for tribal health and Urban Indian Health organizations as part of the emergency federal relief legislation.

While the states received the emergency funds immediately, the CDC disburses the money to tribes, who have yet to receive any. Haaland, the first Native American woman elected to Congress, says the tribes needed the money “yesterday.”

Several days ago, Rodney Bordeaux, president of the Rosebud Sioux Tribe in South Dakota, sent a strongly worded SOS to the directors of the World Health Organization and the Pan American Health Organization about COVID-19, saying, “We have approximately 30,000 tribal members living in south central South Dakota with access to fewer than 200 beds within our reservation.”

Not only were beds woefully inadequate to the needs of potential COVID-19 victims, but tests to find out who might need the beds also were lacking. “We believe that some kits have been sent to the states,” Bordeaux wrote, “but it is the states that have been determining who gets a test and who does not.”

In Michigan, Aaron Payment, chair of the Sault Ste. Marie Tribe of Chippewa Indians, told the Native America Calling radio show, “We’re the largest tribe east of the Mississippi, and we have two test kits.”

The “chronically underfunded” Indian Health Service (IHS) was underprepared for handling virus response, Melissa Riley, PhD, executive director of Indigenous Women Rising, charged in a March 24 opinion piece in Rewire News. “If IHS can barely keep up with broken bones and preventive care,” she wrote, “what makes our people across the country think IHS can handle the outbreak of COVID-19?”  

The Centers for Disease Control and Prevention (CDC) does not break down data on cases according to race or ethnicity, but according to the IHS website, 42 people in the agency’s jurisdiction had tested positive for COVID-19 as of Mar. 24. Of those, 29 were in Navajo Country. By the evening of that day, according to Native News Online, the number of Navajos testing positive had risen to 49. Given the often-invisible spread of the virus, many more are likely to be infected.

The IHS website directs visitors to visit CDC pages for more information. However, these pages do not provide information “in a culturally literate and responsive manner,” Riley says, that explain ways to stay indoors, nor do they offer contacts for indigenous people—despite the fact, she adds, that on the West Coast they were among the first to contract the virus and to reach out with questions.

For its part, the IHS has said it “continues to work closely with our tribal partners to coordinate a comprehensive public health response to COVID-19,” holding weekly conference calls with tribal and urban Indian health organization leaders to “provide updates, answer questions, and hear concerns.” It also is in constant contact with the White House and the CDC, IHS says. IHS facilities “generally” have access to testing for individuals who may have COVID-19, the website says: However, “there are nationwide shortages of materials that may temporarily affect the availability of COVID-19 testing at a particular location.” Tribes, the website recommends, should first follow their usual process for ordering supplies. If they can’t access supplies, they should contact their IHS Area Office, which can access supplies through the IH National Supply Service Center.

Bordeaux, Payment, and Riley are not alone in their criticisms and concerns. Native Americans and Alaska Natives were hit disproportionately during the 2009 H1N1 influenza pandemic: The death rate was 4 times higher than in all other racial and ethnic groups combined. The NIH says AI/ANs are particularly vulnerable to epidemic infections, due to poverty, underlying chronic illnesses (including asthma), and delayed access to care.

Tribes began taking steps early on to protect their members, even before the federal and state governments began requiring such measures. Lummi Nation leaders, in the Pacific Northwest, for instance, began preparing when the virus first appeared in Wuhan in late 2019, according to an article in The Guardian, and declared a state of emergency on March 3—10 days before President Trump did.

The tribe has been “beefing up” emergency plans, reorganizing services, and gathering medical supplies. It also approved $1 million for emergency response, including repurposing a community fitness center into a field hospital. “We quickly recognized the need to make sacrifices for the greater good, in order to protect our people and the wider community,” Dr. Dakotah Lane, medical director of the tribal health service, said in the Guardian interview.

On March 17, the Navajo Nation shut down its 4 casinos after an Arizona tribe member was diagnosed with the virus. President Jonathan Nez says the tribe stands to lose $3 million to $5 million in revenue. But “[t]he health and well-being of our Navajo people is of utmost importance and not just profit,” Nez said in a Navajo Times interview.

In the meantime, bending to pressure from Rep. Deb Haaland (D-NM) and “a handful” of other lawmakers, according to an article in The Guardian, Congress designated $40 million for tribal health and Urban Indian Health organizations as part of the emergency federal relief legislation.

While the states received the emergency funds immediately, the CDC disburses the money to tribes, who have yet to receive any. Haaland, the first Native American woman elected to Congress, says the tribes needed the money “yesterday.”

The Food and Drug Administration has issued a Safety Alert warning of the potential for SARS-CoV-2 transmission through fecal microbiota transplantation and that additional safety procedures may be required.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The risk of SARS-CoV-2 transmission through fecal microbiota transplant is unknown, but “several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals,” the FDA said in the press release. The testing of nasopharyngeal specimens from stool donors may not be available, and the availability and sensitivity of direct testing of stool for SARS-CoV-2 is currently unknown.

Because of the risk of serious adverse events, the FDA has issued several recommendations for any medically necessary usage of fecal microbiota transplantation involving stool samples donated after Dec. 1, 2019.

• Donor screening with questions directed at identifying those currently or recently infected with SARS-CoV-2.
• Testing donors and/or donor stool for SARS-CoV-2, as feasible.
• Development of criteria for exclusion of donors and donor stool based on screening and testing.
• Informed consent that includes information about the potential for transmission of SARS-CoV-2 via fecal microbiota transplantation, including transplantation prepared from stool from donors who are asymptomatic for COVID-19.

“As the scientific community learns more about SARS-CoV-2 and COVID-19, FDA will provide further information as warranted,” the agency said.

lfranki@mdedge.com

The Food and Drug Administration has issued a Safety Alert warning of the potential for SARS-CoV-2 transmission through fecal microbiota transplantation and that additional safety procedures may be required.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The risk of SARS-CoV-2 transmission through fecal microbiota transplant is unknown, but “several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals,” the FDA said in the press release. The testing of nasopharyngeal specimens from stool donors may not be available, and the availability and sensitivity of direct testing of stool for SARS-CoV-2 is currently unknown.

Because of the risk of serious adverse events, the FDA has issued several recommendations for any medically necessary usage of fecal microbiota transplantation involving stool samples donated after Dec. 1, 2019.

• Donor screening with questions directed at identifying those currently or recently infected with SARS-CoV-2.
• Testing donors and/or donor stool for SARS-CoV-2, as feasible.
• Development of criteria for exclusion of donors and donor stool based on screening and testing.
• Informed consent that includes information about the potential for transmission of SARS-CoV-2 via fecal microbiota transplantation, including transplantation prepared from stool from donors who are asymptomatic for COVID-19.

“As the scientific community learns more about SARS-CoV-2 and COVID-19, FDA will provide further information as warranted,” the agency said.

lfranki@mdedge.com

The Food and Drug Administration has issued a Safety Alert warning of the potential for SARS-CoV-2 transmission through fecal microbiota transplantation and that additional safety procedures may be required.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The risk of SARS-CoV-2 transmission through fecal microbiota transplant is unknown, but “several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals,” the FDA said in the press release. The testing of nasopharyngeal specimens from stool donors may not be available, and the availability and sensitivity of direct testing of stool for SARS-CoV-2 is currently unknown.

Because of the risk of serious adverse events, the FDA has issued several recommendations for any medically necessary usage of fecal microbiota transplantation involving stool samples donated after Dec. 1, 2019.

• Donor screening with questions directed at identifying those currently or recently infected with SARS-CoV-2.
• Testing donors and/or donor stool for SARS-CoV-2, as feasible.
• Development of criteria for exclusion of donors and donor stool based on screening and testing.
• Informed consent that includes information about the potential for transmission of SARS-CoV-2 via fecal microbiota transplantation, including transplantation prepared from stool from donors who are asymptomatic for COVID-19.

“As the scientific community learns more about SARS-CoV-2 and COVID-19, FDA will provide further information as warranted,” the agency said.

lfranki@mdedge.com

The Society of Critical Care Medicine released its first set of guidelines for managing critically ill patients with novel coronavirus disease (COVID-19) on March 20, 2020.

The 49 recommendations and statements it included are geared to “support hospital clinicians managing critically ill adults with COVID-19 in the ICU. The target users of this guideline are frontline clinicians, allied health professionals, and policy makers involved in the care of patients with COVID-19 in the ICU,” said the document, written by a panel of 36 experts organized by the Surviving Sepsis Campaign, a joint program of the Society of Critical Care Medicine and the European Society of Intensive Care Medicine.

The document divides the recommendations into four categories: infection control, which includes 3 “best-practice” statements and 5 “weak” recommendations; hemodynamics with 2 “strong” recommendations and 13 weak ones; ventilation, with 1 best-practice statement, 6 strong recommendations, and 12 weak recommendations; and therapy with 7 weak recommendations. The guidelines also included five management questions considered by the writing panel without arriving at a recommendation because of insufficient evidence.

Useful guide nonspecialists

Some critical care medicine physicians saw the new guidelines as offering no surprises, but providing a very useful resource to guide management, especially for clinicians who may become involved in caring for COVID-19 patients despite having little experience caring for patients with acute respiratory distress syndrome (ARDS).

“For those of us who manage ARDS patients all the time, this is not a lot of new information, but many critically ill COVID-19 patients are now being cared for by physicians who have not cared for these patients before,” commented Mangala Narasimhan, DO, FCCP, a critical care medicine physician at Long Island Jewish Medical Center in New Hyde Park, N.Y. In fact, Dr, Narasimhan and associates took the new guidelines soon after their release and used them to create a one-page summary sheet to give to all their colleagues who are now seeing COVID-19 patients, she said in an interview. “The guidelines are very important for clinicians who are suddenly taking care of a roomful of patients with ARDS.”

“A lot of people want to know this information,” agreed David M. Ferraro, MD, FCCP, a pulmonologist and critical care medicine physician at National Jewish Health in Denver.

He also highlighted the value of quickly forgoing continued use of either of these ventilatory approaches in a declining patient and having a low threshold to switch to intubation. “Many clinicians now favor erring on the side of early intubation,” he noted, an approach that the new guidelines endorsed in a best-practice statement: “In adults with COVID-19 receiving NIPPV or HFNC we recommend close monitoring for worsening respiratory status and early intubation in a controlled setting if worsening occurs.”

One aspect of the COVID-19 pandemic that the new guidelines don’t address are some of the challenges being faced from skyrocketing numbers of patients and inadequate supplies and manpower to meet their acute clinical needs. “We need recommendations on how systems should manage when they are overwhelmed,” commented Dr. Ferraro, an omission that he also saw in the COVID-19 management guidance released on March 13, 2020, by the World Health Organization.

“Neither document gets into this in depth, but that wasn’t in their scope,” Dr. Ferraro acknowledged. He said that recommendations on how to deal with scarce resources, inadequate staffing, and the health of clinicians are probably best handled on a state or local level rather than trying to create recommendations that are applicable to the entire U.S. health system.

Dr. Narasimhan and Dr. Ferraro reported that they had no disclosures.

mzoler@mdedge.com

The Society of Critical Care Medicine released its first set of guidelines for managing critically ill patients with novel coronavirus disease (COVID-19) on March 20, 2020.

The 49 recommendations and statements it included are geared to “support hospital clinicians managing critically ill adults with COVID-19 in the ICU. The target users of this guideline are frontline clinicians, allied health professionals, and policy makers involved in the care of patients with COVID-19 in the ICU,” said the document, written by a panel of 36 experts organized by the Surviving Sepsis Campaign, a joint program of the Society of Critical Care Medicine and the European Society of Intensive Care Medicine.

The document divides the recommendations into four categories: infection control, which includes 3 “best-practice” statements and 5 “weak” recommendations; hemodynamics with 2 “strong” recommendations and 13 weak ones; ventilation, with 1 best-practice statement, 6 strong recommendations, and 12 weak recommendations; and therapy with 7 weak recommendations. The guidelines also included five management questions considered by the writing panel without arriving at a recommendation because of insufficient evidence.

Useful guide nonspecialists

Some critical care medicine physicians saw the new guidelines as offering no surprises, but providing a very useful resource to guide management, especially for clinicians who may become involved in caring for COVID-19 patients despite having little experience caring for patients with acute respiratory distress syndrome (ARDS).

“For those of us who manage ARDS patients all the time, this is not a lot of new information, but many critically ill COVID-19 patients are now being cared for by physicians who have not cared for these patients before,” commented Mangala Narasimhan, DO, FCCP, a critical care medicine physician at Long Island Jewish Medical Center in New Hyde Park, N.Y. In fact, Dr, Narasimhan and associates took the new guidelines soon after their release and used them to create a one-page summary sheet to give to all their colleagues who are now seeing COVID-19 patients, she said in an interview. “The guidelines are very important for clinicians who are suddenly taking care of a roomful of patients with ARDS.”

“A lot of people want to know this information,” agreed David M. Ferraro, MD, FCCP, a pulmonologist and critical care medicine physician at National Jewish Health in Denver.

He also highlighted the value of quickly forgoing continued use of either of these ventilatory approaches in a declining patient and having a low threshold to switch to intubation. “Many clinicians now favor erring on the side of early intubation,” he noted, an approach that the new guidelines endorsed in a best-practice statement: “In adults with COVID-19 receiving NIPPV or HFNC we recommend close monitoring for worsening respiratory status and early intubation in a controlled setting if worsening occurs.”

One aspect of the COVID-19 pandemic that the new guidelines don’t address are some of the challenges being faced from skyrocketing numbers of patients and inadequate supplies and manpower to meet their acute clinical needs. “We need recommendations on how systems should manage when they are overwhelmed,” commented Dr. Ferraro, an omission that he also saw in the COVID-19 management guidance released on March 13, 2020, by the World Health Organization.

“Neither document gets into this in depth, but that wasn’t in their scope,” Dr. Ferraro acknowledged. He said that recommendations on how to deal with scarce resources, inadequate staffing, and the health of clinicians are probably best handled on a state or local level rather than trying to create recommendations that are applicable to the entire U.S. health system.

Dr. Narasimhan and Dr. Ferraro reported that they had no disclosures.

mzoler@mdedge.com

The Society of Critical Care Medicine released its first set of guidelines for managing critically ill patients with novel coronavirus disease (COVID-19) on March 20, 2020.

The 49 recommendations and statements it included are geared to “support hospital clinicians managing critically ill adults with COVID-19 in the ICU. The target users of this guideline are frontline clinicians, allied health professionals, and policy makers involved in the care of patients with COVID-19 in the ICU,” said the document, written by a panel of 36 experts organized by the Surviving Sepsis Campaign, a joint program of the Society of Critical Care Medicine and the European Society of Intensive Care Medicine.

The document divides the recommendations into four categories: infection control, which includes 3 “best-practice” statements and 5 “weak” recommendations; hemodynamics with 2 “strong” recommendations and 13 weak ones; ventilation, with 1 best-practice statement, 6 strong recommendations, and 12 weak recommendations; and therapy with 7 weak recommendations. The guidelines also included five management questions considered by the writing panel without arriving at a recommendation because of insufficient evidence.

Useful guide nonspecialists

Some critical care medicine physicians saw the new guidelines as offering no surprises, but providing a very useful resource to guide management, especially for clinicians who may become involved in caring for COVID-19 patients despite having little experience caring for patients with acute respiratory distress syndrome (ARDS).

“For those of us who manage ARDS patients all the time, this is not a lot of new information, but many critically ill COVID-19 patients are now being cared for by physicians who have not cared for these patients before,” commented Mangala Narasimhan, DO, FCCP, a critical care medicine physician at Long Island Jewish Medical Center in New Hyde Park, N.Y. In fact, Dr, Narasimhan and associates took the new guidelines soon after their release and used them to create a one-page summary sheet to give to all their colleagues who are now seeing COVID-19 patients, she said in an interview. “The guidelines are very important for clinicians who are suddenly taking care of a roomful of patients with ARDS.”

“A lot of people want to know this information,” agreed David M. Ferraro, MD, FCCP, a pulmonologist and critical care medicine physician at National Jewish Health in Denver.

He also highlighted the value of quickly forgoing continued use of either of these ventilatory approaches in a declining patient and having a low threshold to switch to intubation. “Many clinicians now favor erring on the side of early intubation,” he noted, an approach that the new guidelines endorsed in a best-practice statement: “In adults with COVID-19 receiving NIPPV or HFNC we recommend close monitoring for worsening respiratory status and early intubation in a controlled setting if worsening occurs.”

One aspect of the COVID-19 pandemic that the new guidelines don’t address are some of the challenges being faced from skyrocketing numbers of patients and inadequate supplies and manpower to meet their acute clinical needs. “We need recommendations on how systems should manage when they are overwhelmed,” commented Dr. Ferraro, an omission that he also saw in the COVID-19 management guidance released on March 13, 2020, by the World Health Organization.

“Neither document gets into this in depth, but that wasn’t in their scope,” Dr. Ferraro acknowledged. He said that recommendations on how to deal with scarce resources, inadequate staffing, and the health of clinicians are probably best handled on a state or local level rather than trying to create recommendations that are applicable to the entire U.S. health system.

Dr. Narasimhan and Dr. Ferraro reported that they had no disclosures.

mzoler@mdedge.com

The Food and Drug Administration has issued Emergency Use Authorizations for three products offering rapid, point-of-care diagnostic tests for COVID-19.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The first authorization, announced by the agency on March 21, was for the Xpert Xpress SARS-CoV-2 test, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19.

The test, manufactured by Cepheid, has a detection time of 45 minutes and has been designed to operate on any of the company’s more than 23,000 automated GeneXpert Systems worldwide, according to a statement from the company.

The agency said in its EUA approval document the test is for a “qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab and/or nasal wash/aspirate specimens collected from patients who are suspected of having COVID-19 infection.” Positive results are indicative of an infection but do not rule out other potential infections, it noted.

The company plans to roll out the test by March 30, according to the FDA.

Cepheid said in a statement that it has almost 5,000 GeneXpert systems in the United States that are capable of point-of-care testing and ready for use in hospitals. “Our automated systems do not require users to have specialty training to perform testing – they are capable of running 24/7, with many systems already doing so today,” Warren Kocmond, the company’s president, said in the statement.

FDA Commissioner Stephen Hahn, MD said in a statement that the authorization marked “an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to the patient in the patient-care settings, like hospitals, urgent care centers, and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”

On March 23, the agency issued an emergency use authorization to bioMerieux subsidiary BioFire Defense LLC for its BIOFIRE COVID-19 test, which detects SARS-CoV-2 from a nasopharyngeal swab in about 45 minutes.

The test was developed with funding from the U.S. Department of Defense.

“Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status,” the agency said in its approval document. It again noted that positive results did not rule out bacterial infection or coinfection with other viruses.

Also on March 23, the agency issued an EUA to Mesa Biotech for its Accula SARS-CoV-2 test, which gives COVID-19 diagnostic results in 30 minutes.

The test is indicated for “qualitative, visual detection of nucleic acid from the SARS-CoV-2 in throat swab and nasal swab specimens combined, collected from patients suspected of COVID-19 by their health care provider,” according to the FDA approval document. “The SARS-CoV-2 nucleic acid is generally detectable in throat and nasal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or coinfection with other viruses.”

Mesa Biotech said in a statement that the test is designed for point-of-care use, including at temporary screening facilities, physician office labs, urgent care, and long-term nursing facilities.

“Our test will provide a highly accessible means for health care professionals to access laboratory quality results close in their office to aid in the decision to isolate, treat, or dismiss potential carriers of the virus,” Hong Cai, the CEO and cofounder of Mesa Biotech, said in a statement. “The potential to reduce the growing strain on our nation’s hospitals is tremendous.”

In separate letters to the three companies notifying them of the authorizations, the FDA said the emergency use of the products met the criteria for issuances of authorization because the SARS-CoV-2 can cause a serious or life-threatening disease or condition; it was “reasonable to believe

that [the] product may be effective in diagnosing COVID-19; and there is no “adequate, approved, and available alternative” to the emergency use of the three products.

gtwachtman@mdedge.com

The Food and Drug Administration has issued Emergency Use Authorizations for three products offering rapid, point-of-care diagnostic tests for COVID-19.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The first authorization, announced by the agency on March 21, was for the Xpert Xpress SARS-CoV-2 test, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19.

The test, manufactured by Cepheid, has a detection time of 45 minutes and has been designed to operate on any of the company’s more than 23,000 automated GeneXpert Systems worldwide, according to a statement from the company.

The agency said in its EUA approval document the test is for a “qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab and/or nasal wash/aspirate specimens collected from patients who are suspected of having COVID-19 infection.” Positive results are indicative of an infection but do not rule out other potential infections, it noted.

The company plans to roll out the test by March 30, according to the FDA.

Cepheid said in a statement that it has almost 5,000 GeneXpert systems in the United States that are capable of point-of-care testing and ready for use in hospitals. “Our automated systems do not require users to have specialty training to perform testing – they are capable of running 24/7, with many systems already doing so today,” Warren Kocmond, the company’s president, said in the statement.

FDA Commissioner Stephen Hahn, MD said in a statement that the authorization marked “an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to the patient in the patient-care settings, like hospitals, urgent care centers, and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”

On March 23, the agency issued an emergency use authorization to bioMerieux subsidiary BioFire Defense LLC for its BIOFIRE COVID-19 test, which detects SARS-CoV-2 from a nasopharyngeal swab in about 45 minutes.

The test was developed with funding from the U.S. Department of Defense.

“Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status,” the agency said in its approval document. It again noted that positive results did not rule out bacterial infection or coinfection with other viruses.

Also on March 23, the agency issued an EUA to Mesa Biotech for its Accula SARS-CoV-2 test, which gives COVID-19 diagnostic results in 30 minutes.

The test is indicated for “qualitative, visual detection of nucleic acid from the SARS-CoV-2 in throat swab and nasal swab specimens combined, collected from patients suspected of COVID-19 by their health care provider,” according to the FDA approval document. “The SARS-CoV-2 nucleic acid is generally detectable in throat and nasal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or coinfection with other viruses.”

Mesa Biotech said in a statement that the test is designed for point-of-care use, including at temporary screening facilities, physician office labs, urgent care, and long-term nursing facilities.

“Our test will provide a highly accessible means for health care professionals to access laboratory quality results close in their office to aid in the decision to isolate, treat, or dismiss potential carriers of the virus,” Hong Cai, the CEO and cofounder of Mesa Biotech, said in a statement. “The potential to reduce the growing strain on our nation’s hospitals is tremendous.”

In separate letters to the three companies notifying them of the authorizations, the FDA said the emergency use of the products met the criteria for issuances of authorization because the SARS-CoV-2 can cause a serious or life-threatening disease or condition; it was “reasonable to believe

that [the] product may be effective in diagnosing COVID-19; and there is no “adequate, approved, and available alternative” to the emergency use of the three products.

gtwachtman@mdedge.com

The Food and Drug Administration has issued Emergency Use Authorizations for three products offering rapid, point-of-care diagnostic tests for COVID-19.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The first authorization, announced by the agency on March 21, was for the Xpert Xpress SARS-CoV-2 test, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19.

The test, manufactured by Cepheid, has a detection time of 45 minutes and has been designed to operate on any of the company’s more than 23,000 automated GeneXpert Systems worldwide, according to a statement from the company.

The agency said in its EUA approval document the test is for a “qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab and/or nasal wash/aspirate specimens collected from patients who are suspected of having COVID-19 infection.” Positive results are indicative of an infection but do not rule out other potential infections, it noted.

The company plans to roll out the test by March 30, according to the FDA.

Cepheid said in a statement that it has almost 5,000 GeneXpert systems in the United States that are capable of point-of-care testing and ready for use in hospitals. “Our automated systems do not require users to have specialty training to perform testing – they are capable of running 24/7, with many systems already doing so today,” Warren Kocmond, the company’s president, said in the statement.

FDA Commissioner Stephen Hahn, MD said in a statement that the authorization marked “an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to the patient in the patient-care settings, like hospitals, urgent care centers, and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”

On March 23, the agency issued an emergency use authorization to bioMerieux subsidiary BioFire Defense LLC for its BIOFIRE COVID-19 test, which detects SARS-CoV-2 from a nasopharyngeal swab in about 45 minutes.

The test was developed with funding from the U.S. Department of Defense.

“Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status,” the agency said in its approval document. It again noted that positive results did not rule out bacterial infection or coinfection with other viruses.

Also on March 23, the agency issued an EUA to Mesa Biotech for its Accula SARS-CoV-2 test, which gives COVID-19 diagnostic results in 30 minutes.

The test is indicated for “qualitative, visual detection of nucleic acid from the SARS-CoV-2 in throat swab and nasal swab specimens combined, collected from patients suspected of COVID-19 by their health care provider,” according to the FDA approval document. “The SARS-CoV-2 nucleic acid is generally detectable in throat and nasal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or coinfection with other viruses.”

Mesa Biotech said in a statement that the test is designed for point-of-care use, including at temporary screening facilities, physician office labs, urgent care, and long-term nursing facilities.

“Our test will provide a highly accessible means for health care professionals to access laboratory quality results close in their office to aid in the decision to isolate, treat, or dismiss potential carriers of the virus,” Hong Cai, the CEO and cofounder of Mesa Biotech, said in a statement. “The potential to reduce the growing strain on our nation’s hospitals is tremendous.”

In separate letters to the three companies notifying them of the authorizations, the FDA said the emergency use of the products met the criteria for issuances of authorization because the SARS-CoV-2 can cause a serious or life-threatening disease or condition; it was “reasonable to believe

that [the] product may be effective in diagnosing COVID-19; and there is no “adequate, approved, and available alternative” to the emergency use of the three products.

gtwachtman@mdedge.com